N/A LF1937Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07613327504897), received between Jan 12, 2022 and Sep 9, 2026 — classified as 3 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50697476 ↗
• MalfunctionSep 9, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50697475 ↗
• MalfunctionJan 7, 2026Difficult to Open or Close; Activation Problem

  IT WAS REPORTED THAT THE LIGASURE DID NOT OPEN AND DID NOT SEAL AS REQUIRED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996690 ↗
• MalfunctionDec 9, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE DEVICE WOULD NOT SEAL/COAGULATE WHEN CLAMPING DOWN. AS REPORTED, THE DEVICE WAS REPLACED WITH A STRYKER DEVICE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23762479 ↗
• MalfunctionApr 16, 2025Use of Device Problem; Failure to Seal; Use of Device Problem; Failure to Seal

  IT WAS REPORTED THAT THE CUTTING POTION OF THE LIGASURE DEVICE WORKED, BUT THE BIPOLAR FUNCTION FAILED SO BLEEDING WAS UNCONTROLLED. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21852371 ↗
• MalfunctionApr 16, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT THE LIGASURE STICKS TO TISSUE, MAKING IT HARD TO RELEASE. AS REPORTED, 3-4 BURNS WERE REQUIRED BEFORE HEMOSTASIS OCCURRED. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21852179 ↗
• MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FOR LIGASURE THAT THE WORKING PART FELL APART. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21230577 ↗
• MalfunctionOct 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE LAP MARYLAND BROKE AND WAS DISJOINTED. THERE WAS NO PATIENT INJURY REPORTED, AND THE COMPLAINANT IS NOT AWARE OF ANY MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20476933 ↗
• InjurySep 4, 2024Continuous Firing; Continuous Firing

  IT WAS REPORTED THAT REPROCESSED MARYLAND LIGASURE WAS NOT TURNING OFF WHEN NOT USED. THIS REQUIRED MEDICAL INTERVENTION. THE COMPLAINANT NOT AWARE OF ANY OTHER PATIENT INJURY OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20136089 ↗
• MalfunctionAug 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TOWARDS THE END OF THE CASE, THE DOCTOR WENT TO CUT TISSUE AND THE TIP OF THE LIGASURE FELL OFF. THE TIP OF LIGASURE STAYED HANGING ON DEVICE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987460 ↗
• MalfunctionMay 24, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT WHEN GRASPING TISSUE, THE COMPLAINT DEVICE DID NOT ACTIVATE AND COMMENT ON THE CONSOLE SAID INCOMPLETE SEAL. THE COMPLAINT DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN TEN MINUTES JUST TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397536 ↗
• MalfunctionMay 24, 2024Output Problem; Output Problem

  IT WAS REPORTED THE COMPLAINT DEVICE DIDN'T WORK AS THE PHYSICIAN TRIED TO CONNECT THE DEVICE TO THE GENERATOR BUT RECEIVED AN ERROR MESSAGE. THE COMPLAINT DEVICE WAS REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE COMPLAINANT IS NOT AWARE OF ANY MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397522 ↗
• MalfunctionMay 24, 2024Output Problem; Output Problem

  IT WAS REPORTED THE COMPLAINT DEVICE WOULD NOT SEAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS A FEW MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397436 ↗
• MalfunctionMay 24, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE COMPLAINT DEVICE WAS WORKING EFFECTIVELY FOR 8-10 BITES THEN PROCEEDED TO NO LONGER SEAL PROPERLY. ENERGY WAS NOT EMITTING THROUGH DEVICE TO SEAL. GENERATOR PRODUCED ERROR READING FOR PROPER SEALING. GENERATOR HAS SOFTWARE 4.1.0.15 ACTIVE. THE COMPLAINT DEVICE WAS REPORTED TO HAVE BEEN REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397118 ↗
• MalfunctionApr 2, 2024Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  IT WAS REPORTED THE DEVICE ARRIVED VISIBLY BROKEN AT THE JAWS WITH DAMAGE TO THE PACKAGING. THE COMPLAINT DEVICE WAS REPLACED AND THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028124 ↗
• MalfunctionMar 28, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THE DEVICE ARRIVED VISIBLY BROKEN AT THE JAWS. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS FOUR MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991597 ↗
• MalfunctionFeb 15, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE DEVICE KEPT ALARMING INCOMPLETE SEAL CYCLE DURING THE CASE. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. HOWEVER, THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18717281 ↗
• MalfunctionJan 16, 2024Energy Output Problem; Activation Problem; Energy Output Problem; Activation Problem

  IT WAS REPORTED THE DEVICE WOULD NOT FIRE NOR SEAL AND THAT AN ERROR CODE APPEARED ON THE GENERATOR. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522862 ↗
• MalfunctionJan 12, 2024Energy Output Problem; Compatibility Problem; Energy Output Problem; Compatibility Problem

  IT WAS REPORTED WHEN THE SURGEON WAS CLAMPING ON TO TISSUE WHEN IT GAVE THE ERROR CODE OF 404, INCOMPLETE SEAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS 15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507339 ↗
• MalfunctionJan 12, 2024Energy Output Problem; Compatibility Problem; Energy Output Problem; Compatibility Problem

  IT WAS REPORTED WHEN THE SURGEON WAS CLAMPING ON TO TISSUE WHEN IT GAVE THE ERROR CODE OF 404, INCOMPLETE SEAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS 15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18506631 ↗
• MalfunctionJan 12, 2024Energy Output Problem; Compatibility Problem; Energy Output Problem; Compatibility Problem

  IT WAS REPORTED WHEN THE SURGEON WAS CLAMPING ON TO TISSUE WHEN IT GAVE THE ERROR CODE OF 404, INCOMPLETE SEAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS 15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18506218 ↗
• MalfunctionJan 12, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED WHEN THE SURGEON WAS CLAMPING ON TO TISSUE WHEN IT GAVE THE ERROR CODE OF 404, INCOMPLETE SEAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS 15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18506200 ↗
• MalfunctionJan 11, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE DEVICE STOPPED WORKING DUE TO AN ISSUE WITH THE JAWS CLAMPING AND NOT RELEASING DURING THE SEALING PROCESS. THERE WAS NO PATIENT IMPACT OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL ONLY TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499048 ↗
• MalfunctionJan 11, 2024Use of Device Problem; Output Problem; Use of Device Problem; Output Problem

  IT WAS REPORTED THE DEVICE STOPPED WORKING DUE TO AN ISSUE WITH THE JAWS CLAMPING AND NOT RELEASING DURING THE SEALING PROCESS. THERE WAS NO PATIENT IMPACT OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL ONLY TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499045 ↗
• MalfunctionJan 11, 2024Use of Device Problem; Activation Problem; Use of Device Problem; Activation Problem

  IT WAS REPORTED THE DEVICE STOPPED WORKING DUE TO AN ISSUE WITH THE JAWS CLAMPING AND NOT RELEASING DURING THE SEALING PROCESS. THERE WAS NO PATIENT IMPACT OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL ONLY TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499025 ↗